Acute Upper Respiratory Tract Infection - When is Bacteria Involved?

• Conditions: Acute Upper Respiratory Tract Infection and Acute Bacterial Rhinosinusitis

• Registration Number: NCT01580137
• Lead Sponsor: Oulu University Hospital

Brief Summary

The purpose of this study is to find out if we can predict the progress of acute upper respiratory tract infection to acute bacterial rhinosinusitis in Finnish conscripts by symptoms, clinical, endoscopic or radiological findings, middle meatal swab samples or nitric oxide measurement.

Detailed Description

We will recruit conscripts with upper respiratory tract infection (common cold) during a two month period. We will recruit non-allergic conscripts. These conscripts should either have not had history of recurrent ABR or they should have experienced recurrent acute (ABR) bacterial rhinosinusitis at least 3 times during the last two years (diagnosed by a doctor and at least one time with x-ray or sinus puncture). The recruits will keep a record of their symptoms. They will be examined by a doctor soon after the symptoms have started (2-4 days) and when the symptoms have lasted about 7-10 days. Clinical examination, nasal endoscopy and ultrasonographic examination of the maxillary sinuses are made, middle meatal specimen for bacteria and bacteria-pcr are taken, virus-pcr samples are taken from the nostril and nasopharynx, Nitric oxide-measurements from both nasal cavities are recorded. Cone beam CT of the maxillary and ethmoidal sinuses is made during the first examination, 2-4 days later and during the last examination. If the last CT-scan shows any other radiological signs than mild mucosal oedema in either maxillary sinus, maxillar sinus puncture is made and secretion is aspirated for culture and PCR. Biopsy from the mucosa of nasal cavity (middle meatal area) is taken to examine the cilia and possible bacteria biofilm.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Conscript with acute upper respiratory tract infection symptoms (nasal obstruction/decongestion, post nasal drip or nasal secretion) lasted for 2-4 days

Exclusion Criteria

• Allergy, asthma, nasal polyposis, sinus surgery, autoimmune illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial maxillary sinusitis	2 months	Bacterial maxillary sinusitis defined as positive culture results from the maxillary puncture (either side)

Secondary Outcome Measures

Name	Time	Method
Bacterial sinusitis	2 months	positive bacterial pcr results from either maxillary sinus

Trial Locations

Locations (1)

Finnish Defence Force, Centre for Military Medicine; 🇫🇮 Kajaani, Kainuu, Finland